B. Braun Recalls Epidural Anesthesia Kits Due to Foreign Matter
B. Braun Medical is recalling 120 units of Customer Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
B. Braun Medical, Inc. (BBMI) has initiated a recall of 120 units of Customer Epidural Anesthesia Trays (Product Catalog Number: 555234). These trays are used for local anesthesia of the skin prior to the insertion of a regional anesthesia needle. The affected products were distributed nationwide in the United States.
The recall was initiated because the 22GA 1-1/2in SafetyGlide Needles included in these convenience kits contain loose polypropylene foreign matter that exceeds release specifications. The foreign matter has been identified as product hub material, which was tested for biocompatibility per ISO 10993 during the product development process.
Healthcare facilities and consumers who possess these specific trays should stop using them and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 0061480957.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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